BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 10183044 · Received June 23, 2020

    Report

    Report Number
    3005862821-2020-00032
    Event Type
    Injury
    Date Received
    June 23, 2020
    Date of Event
    May 17, 2020
    Report Date
    June 1, 2020
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    UDI-DI
    00384841518505
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    1. OKB RECEIVED THE SUSPECTIVE METER AT 06/30/20. 2. RETAINED STRIPS (LOT#: D190710-1) IN OKB'S WAREHOUSE WERE RE-TESTED BY USING RETURN METER (SERIAL#: (B)(6) AND RETAINED METER (SERIAL#: (B)(6) WITH CONTROL SOLUTIONS (LEVEL LOW: BATCH# 8AH1A95, EXP. BY DEC., 2020; LEVEL HIGH: BATCH# 8AH3A15, EXP. BY DEC., 2020), AND RESULTS AS BELOW MET THE ACCEPTANCE CRITERIA (LEVEL LOW: 35~85; LEVEL HIGH: 220~330). 2.1 RETURN METER W/ RETAINED STRIPS: 65/66 (LEVEL LOW) AND 273/278 (LEVEL HIGH). 2.2 RETAINED METER W/ RETAINED STRIPS: 67/70 (LEVEL LOW) AND 291/286 (LEVEL HIGH). 3. METER SETTING AND ALL FUNCTIONS OF THE SUSPECTED DEVICE WERE RE-TESTED, AND ALL OF THEM WERE OPERATED PROPERLY. STANDBY CURRENT OF THE DEVICE WAS RE-CHECKED AND THE CURRENT (1.0 UA) MET ACCEPTANCE CRITERIA (< 55 UA). 4. AS ABOVE, NO NON-CONFORMANCE AND MALFUNCTION OF THE SUSPECTED DEVICE WERE FOUND. THE MATTER MIGHT RESULT FROM USER'S OPERATION OR PRESERVATION. THE ROOT CAUSE OF THE COMPLAINT IS UNABLE TO BE VERIFIED WITHOUT MORE USERS' INFORMATION.

    Description of Event or Problem · 0

    THIS IS A SUPPLEMENTAL REPORT TO INITIAL REPORT 3005862821-2020-00032 TO SUBMIT INVESTIGATION RESULTS FROM THE MANUFACTURER FOR THE SUSPECT DEVICES. DEVICES WERE RETURNED FROM PRODIGY DIABETES CARE ON JUNE 30, 2020 AND AN INVESTIGATION RESULTS OF THE SUSPECT DEVICES WERE COMPLETED BY OK BIOTECH.

    Additional Manufacturer Narrative · 1

    NO NON-CONFORMITY WAS FOUND AFTER OKB REVIEWED ALL MANUFACTURING AND QC RECORDS OF THE SUSPECTED METER (SERIAL#: (B)(4)) AND STRIPS (LOT#: D190710-1). THE METER WAS SHIPPED TO PDC ON 08/04/2016. STRIPS WERE MANUFACTURED ON 07/10/2019 AND WILL EXPIRE IN 07/2021. BECAUSE THE SUSPECTED BGMS WAS NOT RETURNED TO OKB, THE RETAINED METER (SERIAL#: (B)(4)) WAS USED TO RE-TEST, AND THE COMPLAINT SITUATIONS DID NOT OCCUR. BESIDES, DESICCANTS OF RETAINED STRIPS (LOT#: D190710-1) FROM OKB'S WAREHOUSE WERE STILL FUNCTIONAL (ORANGE COLOR). RETAINED STRIPS WERE USED TO RE-TEST WITH IN-HOUSE METER (SERIAL#: (B)(4)) AND CONTROL SOLUTION (LEVEL LOW: BATCH# 8AH1A95, EXP. BY DEC., 2020; LEVEL HIGH: BATCH# 8AH3A15, EXP. BY DEC., 2020), AND RESULTS (LEVEL LOW: 55/60; LEVEL HIGH: 258/257) MET THE ACCEPTANCE CRITERIA (LEVEL LOW: 35~85; LEVEL HIGH: 220~330). THE ROOT CAUSE OF THE COMPLAINT WAS UNABLE TO BE VERIFIED WITHOUT THE SUSPECTED BGMS AND MORE USERS' INFORMATION. THEREFORE, THE COMPLAINT HAD TO BE CLOSED OUT IF NO FURTHER ACTION OR INFORMATION FROM THE USER.

    Description of Event or Problem · 1

    CALLER STATED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2020 AROUND 5:30PM AT A PATIENT CARE FACILITY. CALLER WAS CALLING FOR HER MOTHER WHO IS IN A PATIENT CARE FACILITY. SHE STATED THAT SHE WAS TOLD THAT THE END-USER HAD HER BLOOD GLUCOSE CHECKED WITH HER PRODIGY METER AND GOT A RESULT OF 125MG/DL. CALLER STATED THAT THE FACILITY CALLED THE PARAMEDICS APPROXIMATELY 10-20 MINUTES AFTER DUE TO THE END-USER NOT BEING ABLE TO SIT UP ON HER OWN AND SHE WAS INCOHERENT. THE CALLER DOES NOT KNOW IF ANY ADDITIONAL BLOOD GLUCOSE TESTS WERE PERFORMED WITH THE PRODIGY METER. THERE WERE NO FOOD DRINK OR MEDICATIONS CONSUMED WHILE WAITING FOR PARAMEDICS TO ARRIVE. CALLER DID NOT KNOW HOW LONG IT TOOK PARAMEDICS TO ARRIVE HOWEVER UPON ARRIVAL THE END-USERS BLOOD GLUCOSE WAS 45MG/DL. THE END-USER WAS TRANSPORTED TO (B)(6) MEDICAL CENTER LOCATED AT (B)(6). CALLER DOES NOT KNOW WHAT TREATMENT WAS RECEIVED NOR DOES SHE KNOW WHAT THE DISCHARGE INSTRUCTIONS WERE. CALLER STATED THAT THE END-USER WAS IN THE HOSPITAL FOR 3 DAYS. CALLER ALSO STATED THE END-USER WAS TAKEN OFF 2 MEDICATIONS AFTER SEEKING MEDICAL ATTENTION BUT DOES NOT KNOW WHAT MEDICATIONS THE END USER TAKES NOR, DOES SHE KNOW HER WEIGHT. CALLER REFUSED TO GIVE US THE CONTACT INFORMATION FOR THE FACILITY THE END-USER IS IN TO GET ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648003 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D190710-1 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Hospitalization